MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL XTRA BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SMHX580
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who underwent primary breast augmentation with a 580cc mentor memorygel xtra breast implant experienced right sided ruptured accompanied by device malposition post procedure.The rupture was discovered during explant.Explant and replacement were performed on (b)(6) 2023.
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: device malposition.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on december 8, 2023.The analysis has begun but is not complete at this time.When the investigation and analysis have been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on february 16, 2024.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, microscopic examination, and thickness measurement of the returned device.Visual analysis of the returned sample revealed that the breast implant was found to be ruptured.A microscopic examination was performed, and the cause of the tear could not be identified.Therefore, a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.Based on the current information, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.The process controls and data records collected for the ruptured device are within specification including thickness inspection.Additionally, processes, equipment, or tools that could cause a tear in the shell were evaluated and were identified as a non-contributing factor for the tear found.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 18242600
• Report Number: 1645337-2023-14188
• Device Sequence Number: 7108756
• Product Code: FTR
• UDI-Device Identifier: 10081317027901
• UDI-Public: 10081317027901
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SMHX580
• Device Lot Number: 9733548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/08/2023; 02/16/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/29/2023; 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White